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Federal Register notice: FDA finalizes a list of alternative or streamlined mechanisms for complying with GMP requirements for com...[ Price : $8.95]
FDA publishes a draft guidance entitled Computer Software Assurance for Production and Quality System Software that the agency say...[ Price : $8.95]
FDA approves a Bristol Myers Squibb NDA for plaque psoriasis drug Sotyktu (deucravacitinib), a first-in-class, oral, selective, al...[ Price : $8.95]
BioMarin Pharmaceutical tells FDA a patient participating in the companys hemophilia A Phase 3 gene therapy trial of valoctocogene...[ Price : $8.95]
FDA selects non-profit PATHs chief scientific officer David Kaslow as CBER Office of Vaccines Research and Review director.[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Statement of Identity and Strength Content and Format of L...[ Price : $8.95]
Teva urges the U.S. Supreme Court to dismiss a GlaxoSmithKline argument that the high court should not hear Tevas appeal of a skin...[ Price : $8.95]
FDA clears a Boston Imaging 510(k) for its V7, an ultrasound system said to enhance image clarity.